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GBMC Spine Surgeon Plays Critical Role In
FDA Approval Of New Procedure

Minimally-Invasive X STOP Spinal Implant Positioned To Be
New Standard Of Care For Spinal Stenosis Patients

Baltimore County Woman Set For First Post-Trial Surgery in Maryland On Dec. 20th @ GBMC

BALTIMORE – December 13, 2005 – Middle age and elderly patients experiencing back and leg pain now have a minimally invasive surgical alternative in X STOP, a revolutionary device that recently received approval from the U.S. Food and Drug Administration.  Charles Hartjen, M.D., medical director of the spine section of GBMC’s Joint & Spine Center, was a lead investigator for the X STOP clinical trial and will perform Maryland’s first FDA-approved surgery later this month, on a 76-year-old patient from Baltimore County.
 
“X STOP may soon be the standard of care for patients suffering from spinal stenosis who face debilitating back and leg pain on a daily basis,” said Dr. Hartjen, a resident of northern Baltimore County and a GBMC-affiliated physician for nearly two decades.  “Patients have experienced that this is truly a life-improving surgery.”

One of the patent holders for X STOP (formally known as X STOP Interspinous Process Decompression), Dr. Hartjen performed more than 30 surgeries during the clinical trial at GBMC, which had the largest patient enrollment of nine hospitals and was the only Maryland location.

X STOP is a spinal implant that can be inserted using a minimally invasive procedure requiring only local anesthesia.  Since X STOP is not fixed to any bony structures, it does not result in fusion, thereby allowing patients more mobility and a quicker healing time. The device is designed for patients suffering from lumbar spinal stenosis (LSS), a common spinal condition where space in the spinal canal shrinks, causing nerves to be squeezed and resulting in significant back and leg pain.  Following surgery, patients may experience rapid relief from their symptoms and are usually able to walk out of the hospital within 24 hours due to quick recovery and minimal risk of complications.

On Dec. 20, Dr. Hartjen will perform the X STOP surgery on Marilyn Mains of Smith-Greenspring, who says she has been “hardly able to walk” for a while due to back and leg pain.  “I used to go to the mall, walk around and shop,” Mains said.  “But I haven’t been able to do that in a couple of years.” 
 
Merrie Francis Miller, 75, of Ellicott City, Md., is enjoying a “new life” following X STOP surgery in March 2001 during the clinical trial.

Several months before surgery, Miller was experiencing excruciating pain in her lower back and right leg, and had periods of numbness in the two smallest toes of her right foot for several years prior.  “My previous activities of tennis, three-mile walks, tending and taking care of three gardens, taking care of a family of three and a dozen grandchildren, and general daily normal active living was all severely limited,” Miller said during testimony before an FDA panel exploring X STOP.

Six weeks after surgery, Miller took a granddaughter for a lengthy tour of France, and four years after surgery is free of pain and has full normal movement in any position needing a twist, a bend, or a turn of her back.

Hilda Sparks of Upperco, Md. is another X STOP success story from GBMC. At 68-years-old, Sparks had the surgery during the clinical trial after “four excruciatingly painful attacks caused by two herniated discs.”

“The day after surgery I felt immediate relief and was able to walk without pain,” Sparks said.  Within four weeks I was back on my riding lawn mower again.”

With more than 4,000 successful surgical implants so far, X STOP is rapidly becoming a surgical treatment option of choice for mild to moderate spinal stenosis for patients in Europe and Japan. GBMC’s Dr. Hartjen has trained the head of the Swedish Spine Study Group in this surgical technique, and has received requests from physicians across the United States to learn the technique.

About GBMC
GBMC includes Greater Baltimore Medical Center (GBMC), Central Maryland’s leading community hospital; Hospice of Baltimore, which provides comfort and care to patients with life-limiting illnesses; the Harry and Jeanette Weinberg Community Health Center, which offers comprehensive health and family services to the residents of East Baltimore; and the GBMC Foundation, which supports the GBMC mission by managing fundraising efforts.  The 300-bed Medical Center, located on a beautiful suburban campus, serves nearly 22,000 inpatients annually and provides approximately 50,000 emergency room visits. For more information, go to www.gbmc.org.

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